inforMED
OGEClass II

Epidural Anesthesia Kit

Anesthesiology · 21 CFR 868.5120

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

MDR events1,130All time
Recalls33All time
Registered firms37Currently listed
510(k) clearances0All time

Recalls

33 recall events for this product code

See all →

510(k) clearances

0 clearances for this product code

See all →

No 510(k) clearances on file for this product code.